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anti-hepatitis-B therapy (IMMUNO HBS / UMANBIG / IMMUNOHBS)

✓ Approved

Kedrion · 多克隆抗体 · 多克隆抗体

什么是 anti-hepatitis-B therapy？

anti-hepatitis-B therapy 是一种多克隆抗体，由Kedrion研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intramuscular (IM) Injection、Intravenous (IV)。

药物档案

商品名IMMUNO HBS, UMANBIG, IMMUNOHBS
公司Kedrion
药物类别多克隆抗体, 抗体
给药途径Injectable (Others), Intramuscular (IM) Injection, Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, Kedrion

治疗适应症

anti-hepatitis-B therapy 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Infections and infestationsHepatitis B✓ Approved

相关研究文献

PubMedHepatology (Baltimore, Md.)2026-08-04

Nucleos(t)ide withdrawal vs Nucleos(t)ide withdrawal with adjuvant pegylated-interferon in HBeAg-negative hepatitis B virus infection (NUC-B Trial).

Thursz Mark M, Lemoine Maud M, Brown Ashley A, Carey Ivana I et al.

Finite therapy resulting in sustained hepatitis B surface antigen (HBsAg) loss for patients with chronic HBV infection (CHB) is an important therapeutic goal. In patients with HBeAg-negative infection, nucleos(t)ide analogue (NA) withdrawal may achieve HBsAg loss in 5-20% of patients after 3 years. Pegylated interferon (PEG-IFNa) is a recognised treatment for CHB. NUC-B was a randomised, multi-centre trial in NA-treated non-cirrhotic HBeAg negative patients with CHB. Patients were allocated to either NA withdrawal alone (control) or NA withdrawal followed by a 16 week course of PEG-IFNa 180ug weekly commencing 4 weeks after NA cessation (PEG-IFNa). The primary endpoint was HBsAg loss at 3 years. The target recruitment of 240 patients was not achieved. 156 patients, 82 to control arm , 74 to PEG-IFNa arm , were recruited between 2017 and 2021; median age 45 years, 24% female, HBV Genotypes -A 16%, B 6%, C 4%, D 24%, E 22%, other 1%, unknown 26%. At 3 years 3% of patients in the contol arm and 14% of patients in the PEG-IFNa arm lost HBsAg (odds ratio 5.39; 95% confidence interval, (1.11, 26.19); p=0.037). In the control arm 34.9% of patients returned to NA therapy compared to 28.4% in the PEG_IFNa- arm. Exaggerated flares occurred in 27.9% of patients in the control arm compared with 13.4% in the PEG-IFNa arm. The use of adjuvant PEG-IFNa therapy after withdrawal of NA therapy increases the rate of HBsAg loss whilst simultaneously reducing the number of exaggerated flares.

PMID 42549812
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PubMedBrazilian journal of microbiology : [publication of the Brazilian Society for Microbiology]2026-08-04

Distribution of hepatitis B virus genotypes and demography in the general population of Karachi, Sindh.

Farooq Saba S, Iqbal Hana'a H, Faiz Sirmast S, Ahsan Farwa F et al.

Hepatitis B is a major global burden, with 253 million infected people. There are at least ten Hepatitis B virus (HBV) genotypes and 35 subgenotypes, with distinct ethno-geographical distributions and manifest differences in their biological characteristics, display close association with clinical outcomes, severity of disease, and response to antiviral therapy. The aim of the study was to identify the predominant circulating genotypes of HBV in the population of Karachi, Sindh. A demographic assessment was conducted alongside a serological evaluation of markers specifically HBsAg, HBsAb, HBeAb, and HBcAb to determine the clinical infection profile of the study cohort. An initial molecular identification was performed by first round of PCR via specific primers P1 and S1-2 for PreS1/S2 gene. The HBV genotypes (A to F) was determined by nested PCR using primer pairs for the conserved sequence of HBV pre-S gene and S gene, and subsequently validated by phylogenetic analysis. The study findings indicated that the mean age of the study participants was 33.94 years, with a median age of 31.5 years. The percentage of HBV positive female and male were 51.5% and 48.5%, respectively. The results of this pilot study indicated that the probable predominant genotype circulating in Karachi is D, followed by B and C. Mixed infection of B, C, and D was also observed. Almost all the D positive samples were positive for HBsAg.

PMID 42547661
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PubMedHepatology international2026-08-04

National guideline for hepatitis B elimination in Thailand: a decentralized health system model for expanding diagnosis and treatment.

Charatcharoenwitthaya Phunchai P, Tanwandee Tawesak T, Tangkijvanich Pisit P, Piratvisuth Teerha T et al.

Despite sustained universal infant hepatitis B vaccination, chronic hepatitis B (CHB) remains an important cause of cirrhosis and hepatocellular carcinoma in Thailand, particularly among adults born before vaccine implementation. This article summarizes the 2026 National Guideline on Elimination of Viral Hepatitis B in Thailand and presents a health-system framework for addressing the remaining disease burden. The guideline was developed by a multidisciplinary expert panel using evidence from international recommendations, peer-reviewed literature, national epidemiological data, implementation studies, and health economic analyses. The recommendations were formulated using the GRADE framework and adapted for implementation within Thailand's Universal Health Coverage system. The national strategy prioritizes birth-cohort HBsAg screening for adults born before 1992, simplified evidence-based treatment eligibility incorporating non-invasive fibrosis assessment and virological criteria, and first-line use of high genetic-barrier nucleos(t)ide analogs. Prevention of mother-to-child transmission prioritizes HBV DNA-guided antiviral prophylaxis, with simplified implementation pathways reserved for settings with substantial diagnostic constraints. Long-term care emphasizes structured monitoring, appropriate specialist referral, conservative treatment discontinuation criteria, defined retreatment thresholds, and risk-based semiannual ultrasound surveillance for hepatocellular carcinoma. Integration with antenatal services, HIV programs, and primary care facilities supports decentralized delivery and continuity of care. Thailand's 2026 hepatitis B guideline operationalizes evidence-based CHB management within a publicly financed decentralized health system and provides a scalable model for expanding hepatitis B diagnosis and treatment in endemic settings.

PMID 42547747
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PubMedFrontiers in medicine2026-08-04

The efficacy of traditional Chinese medicine on immune function in patients with hepatitis B-related liver fibrosis or cirrhosis: a systematic review and meta-analysis.

Wu Zhulin Z, Tan Wanjun W, Luo Beier B, Liu Xiaowei X et al.

Currently, there is no effective treatment to reverse hepatitis B-related liver fibrosis or cirrhosis. Current nucleos(t)ide analogs (NAs) control but rarely eliminate hepatitis B virus (HBV), leaving chronic hepatitis B at risk of developing liver fibrosis/cirrhosis. Traditional Chinese medicine (TCM) shows promise in slowing the progression of hepatitis B-related liver fibrosis/cirrhosis, but its impact on immune function remains debated. The electronic databases, including Chinese National Knowledge Infrastructure, Wanfang, SinoMed, Weipu, PubMed, Web of Science, EMBASE, and Cochrane databases, were retrieved (April 7, 2026), and the randomized controlled trials (RCTs) that met the inclusion criteria were included. Methodologic quality assessment of the included RCTs was done based on the Cochrane RoB 2 tool. Subsequently, the valid data were screened and analyzed by meta-analysis with Review Manager 5.4.1, and the quality of the evidence was assessed using the GRADE method. This study was registered in the PROSPERO (CRD420261351373). Finally, 25 RCTs were included, containing 2,585 patients with hepatitis B-related liver fibrosis or cirrhosis. Risk of bias evaluations suggested some concerns for the majority of RCTs. The results of meta-analysis indicated that TCM with NAs could improve CD3 + [MD = 5.83, 95%CI (3.93, 7.73), p < 0.00001], CD4 + [MD = 4.32, 95%CI (3.56, 5.08), p < 0.00001], CD4+/CD8 + [MD = 0.24, 95%CI (0.18, 0.29), p < 0.00001], and NK cells, and decrease CD8 + cells [MD = -2.67, 95%CI (-3.46, -1.89), p < 0.00001], interleukin (IL)-6, transforming growth factor (TGF-β), tumor necrosis factor-α (TNF-α), hyaluronic acid (HA), laminin (LN), type IV collagen (IV-C), type III procollagen (PC-III), liver stiffness measurement (LSM), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and albumin in serum compared with NAs alone. Moreover, descriptive data showed that TCM was safe, and the funnel plot suggested the included research might have slight publication bias. The GRADE classification showed that the certainty of evidence was low for the immune function, liver function, and liver fibrosis indexes. A combination of NAs and TCM could improve immune cell metrics, cytokines, liver function indexes, and liver fibrosis indexes of patients with hepatitis B-related liver fibrosis or cirrhosis. Due to the low quality of research, more high-quality RCTs are needed to improve the level of evidence. https://www.crd.york.ac.uk/PROSPERO/view/CRD420261351373.

PMID 42548801
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PubMedMultiple sclerosis (Houndmills, Basingstoke, England)2026-08-04

Borrelia miyamotoi meningoradiculitis complicating ocrelizumab treatment for multiple sclerosis: A report of three cases.

Nicolas Philippe P, Beigneux Ysoline Y, Guennoc Anne-Marie AM, Destras Gregory G et al.

Ocrelizumab is an anti-CD20 monoclonal antibody that is highly effective in multiple sclerosis (MS) but is associated with an increased risk of opportunistic infections that may be difficult to diagnose. We report three MS patients treated with ocrelizumab who developed severe meningoradiculitis. Routine investigations failed to identify any pathogen, whereas metatranscriptomic analysis of cerebrospinal fluid (CSF) detected Borrelia miyamotoi RNA. All patients improved after appropriate antibiotic therapy. B. miyamotoi should be considered in anti-CD20-treated MS patients presenting with meningoradiculitis, and CSF metatranscriptomics should be used to investigate undiagnosed central or peripheral nervous system infections, particularly in immunocompromised individuals. Ocrelizumab is a highly effective treatment widely used in MS but has been associated with an increased risk of infection. We report three cases of B. miyamotoi infections in patients receiving ocrelizumab in which routine laboratory tests failed to detect the pathogen.

PMID 42548291
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PubMedInfectious diseases (London, England)2026-08-04

Clinical and virological characteristics of hepatitis B virus genotype E infection: a case series.

Tiecco Giorgio G, De Francesco Maria Antonia MA, Zeneli Laert L, Gottardi Federica F et al.

Hepatitis B virus (HBV) genotype E, mainly found in sub-Saharan Africa, exhibits low genetic diversity, unique molecular markers and high recombination potential but remains under-studied. This study describes the clinical and virological characteristics, mutational profiles, antiviral treatment responses and phylogenetic data of patients with confirmed HBV genotype E infection in a tertiary-care centre in northern Italy. A retrospective monocentric study was conducted at ASST Spedali Civili di Brescia, Italy, from 2015 to 2023. Patients with documented HBV genotype E who underwent genotypic resistance testing (GRT) for clinical reasons were included. Direct sequencing of the S/POL region was used for genotyping and mutation analysis, interpreted via Geno2pheno [hbv] 2.0 and Stanford HBV resistance tools. Eight patients were identified, mostly male (62.5%) and of African origin (87.5%), with a median age of 38.5 years. GRT was performed in six (75%) patients because of persistent viremia despite antiviral treatment, five (83.3%) of whom were HIV/HBV coinfected with detectable HIV viral load. Lamivudine resistance mutations (L180M, M204V) were found in one (12.5%) case, tenofovir resistance-associated mutations (M267L/I) in two (25%) and immune escape mutations in three (37.5%), including T126I, D144E and G145R. Despite GRT, treatment was not modified in four (50%) patients due to poor adherence concerns. Therapy adjustments led to viral suppression in three (37.5%) cases. In our setting, HBV genotype E infections largely occurred among migrants from endemic regions. Although nucleos(t)ide analogues are effective across genotypes, suboptimal adherence may hinder viral suppression and promote resistance.

PMID 42547309
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